510(k) K131727 ยท LFR Glucose Dehydrogenase, Glucose
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Ceragem Medisys, Inc., Cheonan Si, Chungcheongnam-Do, KR |
| Decision | Substantially Equivalent, Feb 28, 2014 |
| Received | Jun 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131727
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.